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FDA authorizes first COVID-19 test for asymptomatic cases

The federal government's approval expands the test to anyone, not just those who feel sick, and also allows for pooling samples to save supplies and screen faster.

WASHINGTON — The U.S. has authorized the first COVID-19 test for people without symptoms or those with no reason to think that they're infected with the coronavirus. The Food and Drug Administration's approval is also the second to allow pooled sample testing.

The FDA said that it reissued its emergency authorization on Friday for the LabCorp COVID-19 RT-PCR Test to include the two new indications for use: allowing pooled testing and those who are asymptomatic or don't suspect they have the virus.

The FDA says it OK'd the test's expansion for anyone after LabCorp provided scientific data showing the test's efficiency. The test requires a prescription.

The reissued authorization is the second to allow testing of pooled samples, letting the company screen up to five individual swabs at time. The first COVID-19 test that could be used with pooled samples was approved last week.

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Officials say pooling helps conserve resources and possibly allow more tests to be evaluated faster. FDA Commissioner Dr. Stephen Hahn says it's a significant step toward the kind of broad testing needed to maybe enable schools and workplaces to reopen.

"By authorizing another test for use with pooled samples, we also further help increase the possibility that patients may be able to receive results sooner, while also conserving vital testing supplies, which are under increased demand during the pandemic," he said in a statement.

Credit: AP
Food and Drug Administration Commissioner Dr. Stephen Hahn testifies before a Senate Health, Education, Labor and Pensions Committee hearing on the coronavirus on Capitol Hill, Tuesday, March 3, 2020, in Washington. (AP Photo/Andrew Harnik)

The LabCorp test was originally authorized in March for only people suspected of having COVID-19, and didn't screen specimens through sample pooling.

Officials say Friday's authorization allows health care providers to limit risk factors like exposure or community spread when testing people.

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